BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 7328039 · Received March 9, 2018

    Report

    Report Number
    2247858-2018-00091
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    November 28, 2014
    Report Date
    March 9, 2018
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL AUDIT, IT WAS DETERMINED THAT COMPLAINTS FOR SIMILAR DEVICES, AND DEVICE MALFUNCTIONS THAT HAVE THE POTENTIAL TO HARM THE PATIENT IF THEY WERE TO RECUR, WERE NOT REPORTED AS PER FDA GUIDANCE. AFTER RETROSPECTIVE REVIEW, THIS EVENT IS DETERMINED TO BE MDR REPORTABLE. BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A TREOVANCE DEVICE. THE TREOVANCE DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038).

    Description of Event or Problem · 1

    "WHEN THE TREOVANCE MAIN BODY WAS TAKEN OUT FROM THE PATIENT, THE TIP OF THE NAVITEL DELIVERY SYSTEM REMAINED INSIDE THE PATIENT 2-3 CM ABOVE THE FEMORAL ARTERY CUT-DOWN. THE DOCTOR HAD TO LENGTHEN THE INCISION TO EXTRACT THE TIP." PATIENT OUTCOME: "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172125 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B131115137

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Required Intervention